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Trial Title:
Integrated Smartphone Technology to Alleviate Malignant Pain (I-STAMP) Testing
NCT ID:
NCT06117709
Condition:
Advanced Cancer
Pain
Conditions: Keywords:
Advanced Cancer
Pain management
Opioid pain management
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
I-STAMP
Description:
A patient-facing smartphone application that hosts participants' analgesic and laxative
medications, provides pain-specific psychoeducation, collects patient reported outcomes,
and provides feedback to participant symptoms.
Arm group label:
I-STAMP Testing
Summary:
The purpose of the study is to evaluate if the smartphone app, I-STAMP (Integrated
Smartphone Technology to Alleviate Malignant Pain), helps participants with cancer pain
manage symptoms and keep track of medications.
Detailed description:
The goal of this study is to develop and refine I-STAMP (Integrated Smartphone Technology
to Alleviate Malignant Pain), an electronic health record-integrated mobile health
(mHealth) application designed to support advanced cancer patients and care teams in pain
management.
The research study procedures include screening for eligibility, surveys, and interviews.
It is expected that up to 73 participants will take part in this research study.
Activities 1-3 are non-interventional and will be used to collect data for application
development.
Activity 4: This activity will be interventional and will be added with a future
amendment.
Criteria for eligibility:
Criteria:
Inclusion Criteria for Participants (Activities 1a, 2a, 3a):
- Age ≥ 21 years
- Current or previous diagnosis of advanced cancer
- Current or previous experience with cancer pain
Exclusion Criteria for Participants (Activities 1a, 2a, 3a):
- Inability to understand, speak, or read English
- Any condition that would impede the patient's ability to complete study procedures
such as visual impairment or significant cognitive impairment as determined by the
participant's treating provider.
Gender:
All
Minimum age:
21 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Contact:
Last name:
Andrea Enzinger, MD
Phone:
617-582-7335
Email:
andrea_enzinger@dfci.harvard.edu
Investigator:
Last name:
Andrea Enzinger, MD
Email:
Principal Investigator
Start date:
December 2024
Completion date:
May 30, 2025
Lead sponsor:
Agency:
Dana-Farber Cancer Institute
Agency class:
Other
Collaborator:
Agency:
The Fund for Innovation in Cancer Informatics
Agency class:
Other
Source:
Dana-Farber Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06117709
